← Product Code [LMD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD) · K952533

# SIENET DICOM GATEWAY (K952533)

_Siemens AG · LMD · Aug 23, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K952533

## Device Facts

- **Applicant:** Siemens AG
- **Product Code:** [LMD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD.md)
- **Decision Date:** Aug 23, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2020
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K952533](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K952533)

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